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NOxGuard

Proactive control of nitrosamine risks

Understanding nitrosamines – a hidden threat to patient safety

Nitrosamines are probably carcinogenic and can be caused during the production of drugs, for example when secondary or tertiary amines react with nitrosating agents such as NO2. Their formation is hard to predict and can happen at different points in the production process. Since the discovery of contaminants in active ingredients such as valsartan, ranitidine, and metformin, the EMA, FDA, and WHO have introduced stricter risk assessments and controls for nitrosamines.

NOxGuard – prevention built into the process

Traditional controls on the end product are no longer sufficient. Prevention must begin in the process, where nitrosamines can form in the first place.

With NOxGuard, Glatt has developed a technology that reduces NO₂ in fluid bed and coating equipment, combining it with real-time monitoring. It minimizes the risk of nitrosamine formation, can be integrated into new equipment or as a retrofit, and helps you to future-proof your processes.

Key features of NOxGuard

By integrating prevention, monitoring, and control into one solution, NOxGuard transforms nitrosamine risk management from a reactive task into a controlled, reliable process:

  • Prevention

    of the formation of nitrosamines

  • Continuous monitoring

    of the NO₂ level

  • Detection

    of critical limits before nitrosamines can be formed

  • Warning

    if critical thresholds are exceeded

  • Enabling

    rapid process adjustment

From detection to perfection – a future proof approach to nitrosamine control

With rising regulatory scrutiny and growing awareness of nitrosamine risks, preventive solutions are no longer optional – they are essential. NOxGuard supports pharmaceutical manufacturers in taking a decisive step forward: from reacting to contamination events to actively preventing them, safeguarding both product quality and patient trust.

Your advantages at a glance:

  • Enhanced patient safety

    by minimizing the risk of nitrosamine formation directly at its source

  • Full regulatory compliance

    through continuous monitoring, traceable documentation, and alignment with global expectations from authorities such as FDA and WHO

  • Maximum process reliability

    thanks to real-time data, early warnings, and intelligent control logic

  • Seamless integration

    into fluid bed and coating systems

  • Cost reduction

    by avoiding batch failures, product recalls, and unnecessary destruction of valuable product

  • Retrofit-capable

    existing systems can be easily retrofitted

Existing systems, maximum nitrosamine protection

The retrofit capability is particularly valuable for manufacturers operating established plants. Existing systems can be upgraded efficiently without extensive rebuilding, allowing companies to future-proof their production while keeping investment and downtime to a minimum.

Contact us for your new nitrosamine-safe equipment or a retrofit!

Don’t wait for nitrosamines to become a problem in your process. Discover how NOxGuard can help you achieve robust compliance, protect patients, and secure your production for the future.